Cardio-Oncology Registry

Recruiting

• Conditions: Cancer; Arrhythmia; Cardiac Disease; Metabolic Syndrome; Heart Diseases

• Registration Number: NCT04407780
• Lead Sponsor: European Georges Pompidou Hospital

Brief Summary

Cardio-oncology is an emerging field. Most of the data available have been issued from either retrospective analysis, industry data or pharmacovigilance data. These data sources include a number of bias.

CONFUCIUS is a single tertiary centre prospective registry including all patients who have been referred for cardio-oncology assessemnt.

The objectives are to provide a comprehensive vue of cardoi-oncology, enable to detect early signals of cardiotoxicity and enhance ancillary projetcts aiming at specific populations (e.g., type of cancer) and/or drugs.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Status Verified: 2020-05
• Study First Submitted: 2020-05-14
• Study First Submitted QC: 2020-05-25
• Last Update Submitted: 2020-05-25
• Study First Posted: 2020-05-29
• Last Update Posted: 2020-05-29
• Primary Completion: 2022-06-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• referred to cardio-oncology

Exclusion Criteria

• refusal to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of cardio-toxicty	5 years	Number of patients with cardiotoxicity in a cohort of patients referred to a cardio-oncology clinic

Secondary Outcome Measures

Name	Time	Method
Analysis of cardioprotective strategies	5 years	Correlation between the use of cardiovascular drugs and the number of patients with cardiotoxicity.
Analysis of underlying cardiovacsular profile	5 years	Correlation between underlying cardioascular profile and the number of patients with cardiotoxicity.
Cardiovascular outcomes	10 years	Assess cardiovascular outcomes (cardiovascular death, admission for heart failure, acute coronary syndrome, stroke).
Behaviour	5 years	Correlation of any behaviour treatment (exercice, rehabilitation, nutrition consultation) and the number of patents with cardiotoxocity.
Metabolic	5 years	Correlation between oncology treatments, cardiovascular therapies, behaviour therapies and the number of patients with metabolic disorders (diabetes or dyslipidemia).
Oncology	5 years	Adherence to oncology treatment plan as stated in the multidisciplinary team meeting in patients with cardio-oncology assessment compared to matched patients with no cardio-oncology assessment within our institution; outcomes.
Any advserse event	5 years	Correlation between any adverse event, oncology treatment, and outcomes.
Analysis of arrhythmias	5 years	Correlation between incident arrhythmias and cancer drugs
Precision medicine	5 years	Correlation between biomarkers with use of artificial intelligence and the number of patients with cardiotoxicity.
Analysis of cardiotoxicity	5 years	Correlation of cardio-toxicity overall, and in predefined subgroups; statistical associatoin with outcomes.

Trial Locations

Locations (1)

Assistance Publique Hôpitaux de Paris - Centre Université de Paris; 🇫🇷 Paris, France